COMPOUND MACROGOL PAEDIATRIC

Posology Chronic constipation The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children aged 7 – 11 years. The dose should be adjusted up or down as required to produce regular soft stools.

If the dose needs increasing this is best done every second day. The maximum dose needed does not normally exceed 4 sachets a day. Treatment of children with chronic constipation needs to be or a prolonged period (at least 6 – 12 months).

However, safety and efficacy of STRIGOL Paediatric has only been proved for a period of up to three months. Treatment should be stopped gradually and resumed if constipation recurs. Faecal impaction A course of treatment for faecal impaction with STRIGOL Paediatric is for up to 7 days as follows: Daily dosage regimen: Number of STRIGOL Paediatric sachets Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 5 - 11 4 6 8 10 12 12 12 The daily number of sachets should be taken in divided doses, all consumed within a 12 hour period.

The above dosage regimen should be stopped once disimpaction has occurred. An indicator of disimpaction is the passage of a large volume of stools. After disimpaction it is recommended that the child follows an appropriate bowel management program to prevent reimpaction (dosing for prevention of re-impaction should be as for patients with chronic constipation; see above).

STRIGOL Paediatric is not recommended for children below five years of age for the treatment of faecal impaction, or in children below two years of age for the treatment of chronic constipation. For patients of 12 years and older it is recommended to use STRIGOL Paediatric.

Patients with impaired cardiovascular function:

There are no clinical data for this group of patients. Therefore STRIGOL Paediatric is not recommended for treating faecal impaction in children with impaired cardiovascular function.

Patients with renal insufficiency:

There are no clinical data for this group of patients. Therefore STRIGOL Paediatric is not recommended for treating faecal impaction in children with impaired renal function. 5 ml (quarter of a glass) of water. The correct number of sachets may be reconstituted in advance and kept covered and refrigerated for up to 24 hours.

8. g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Compound Macrogol should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately. g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered.

g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Macrogol should be stopped immediately, electrolytes measured, and any abnormality treated appropriately. 5). 230) of potassium per sachet. This should be taken into consideration if the patient takes more than one sachet daily and has reduced kidney function or is on a controlled potassium diet.

3% of the WHO recommended maximum daily intake for sodium. When used long term for constipation the maximum daily dose of this product is equivalent to 28% of the WHO recommended maximum daily intake for sodium. STRIGOL is considered high in sodium.

This should be particularly taken into account for those on a low salt diet. 5. 72 g, powder for oral solution in children, therefore it should not be used in children below 12 years of age. 5 Interaction with other medicinal products and other forms of interaction Macrogol raises the solubility of medicinal products that are soluble in alcohol and relatively insoluble in water.

4). g. anti-epileptics. STRIGOL may result in a potential interactive effect when used with starch-based food thickeners. The polyethylene glycol (PEG) ingredient counteracts the thickening effect of starch, effectively liquefying preparations that need to remain thick for people with swallowing problems.

6 Fertility, pregnancy and lactation Pregnancy There are limited amount of data from the use of STRIGOL Paediatric in pregnant women. 3). Clinically, no effects during pregnancy are anticipated, since systemic exposure to macrogol 3350 is negligible.

The fluid content of Compound Macrogol when re-constituted with water does not replace regular fluid intake and adequate fluid intake must be maintained. Diagnosis of impaction/faecal loading of the rectum should be confirmed by physical or radiological examination of the abdomen and rectum.

8. g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Compound Macrogol should be stopped immediately and electrolytes measured, and any abnormality should be treated appropriately. g. the elderly, patients with impaired hepatic or renal function or patients taking diuretics) and electrolyte control should be considered.

g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure) Macrogol should be stopped immediately, electrolytes measured, and any abnormality treated appropriately. 5). 230) of potassium per sachet. This should be taken into consideration if the patient takes more than one sachet daily and has reduced kidney function or is on a controlled potassium diet.

3% of the WHO recommended maximum daily intake for sodium. When used long term for constipation the maximum daily dose of this product is equivalent to 28% of the WHO recommended maximum daily intake for sodium. STRIGOL is considered high in sodium.

This should be particularly taken into account for those on a low salt diet. In patients with swallowing problems, who need the addition of a thickener to solutions to enhance an appropriate intake, interactions should be considered, see section

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic megacolon. 1.